Deployment device for a soft tissue repair prosthesis

ABSTRACT

A deployment device for positioning a soft tissue repair prosthesis includes a self-expanding support body releasably attachable to the prosthesis. The support body may be removably insertable into a pocket of the prosthesis. A handle coupled to the support body facilitates positioning the patch and/or removal of the support body from the pocket. The support body may substantially occupy the pocket in an expanded configuration. The handle may be arranged to direct a pulling force to the outer peripheral edge of the support body and/or cause a portion thereof to be pulled downward and below the body during withdrawal of the deployment device from the prosthesis. The support body may include support segments pivotally coupled together and foldable to collapse the support body for insertion into and removal from the pocket. One or more resilient support members may be provided for collapsing and expanding the support body and the prosthesis.

RELATED APPLICATIONS

This application is a divisional of U.S. Application No. 16/560,677,filed Sep. 4, 2019, which is a divisional of U.S. Application No.15/386,939, filed Dec. 21, 2016, which claims the benefit of U.S.Provisional Application No. 62/372,525, filed Aug. 9, 2016 and U.S.Provisional Application No. 62/271,896, filed Dec. 28, 2015. The entirecontents of these applications are incorporated herein by reference intheir entirety.

FIELD

A deployment device for a soft tissue repair prosthesis.

BACKGROUND

A hernia defect is an opening or weakness in a tissue or muscle wall,such as the abdominal wall. One approach for repairing a hernia is tocover the tissue or muscle wall defect with a patch of repair fabric.The patch may be placed in an open procedure or through a minimallyinvasive procedure, such as by a laparoscopic technique.

In a hernia repair procedure, a patch may be delivered through asurgical incision to a treatment site within the patient. Because thepatch is typically larger than the pathway to the surgical site, thepatch may be reduced in size to enable passage through the surgicalopening into the patient. After deployment at the treatment site, thepatch needs to return to an enlarged shape sufficient to cover thedefect. Certain hernia repair patches include a resilient supportmember, such as an elastic filament, that is collapsed along with thepatch into a reduced configuration and delivered through the surgicalopening. After delivery through the incision, the resilient supportmember opens, such as by unfurling if rolled into the reducedconfiguration, causing the associated patch to expand into the enlargedrepair configuration. The expanded patch including the resilient supportmember is then fixated to the tissue or muscle wall over the defect.

SUMMARY

According to one aspect, a deployment device for a soft tissue repairprosthesis comprises a self-expanding support body and a handle coupledto the support body. The support body is to be releasably coupled to thesoft tissue repair prosthesis to assist in spreading the soft tissuerepair prosthesis from a reduced configuration to an expandedconfiguration. The support body is collapsible from an expandedconfiguration to a reduced configuration. The handle includes a distalend and a free end opposite the distal end. The distal end of the handleis coupled to the support body to position the soft tissue repairprosthesis relative to a soft tissue defect when the support body iscoupled to the soft tissue repair prosthesis and to release the supportbody from the soft tissue repair prosthesis with a pulling force on thefree end of the handle in an outward direction away from the soft tissuerepair prosthesis when the soft tissue repair prosthesis is in theexpanded configuration. The distal end of the handle is coupled to aportion of the support body to apply the pulling force and collapse theportion of the support body in an inward direction toward the softtissue repair prosthesis. The support body is manipulable into thereduced configuration with the soft tissue repair prosthesis forinsertion through a surgical opening into a patient.

According to another aspect, a method is provided for repairing a herniadefect. The method comprises an act of (a) delivering a prosthesis in areduced configuration through a surgical opening into a patient. Theprosthesis includes a patch body and a deployment device. The deploymentdevice includes a self-expanding support body and a handle coupled tothe support body. The support body is releasably coupled to the patchbody to assist in spreading the patch body to an expanded configuration.The method further comprises acts of: (b) following act (a), spreadingthe patch body to the expanded configuration via the support body, (c)securing the patch body in the expanded configuration about the herniadefect, (d) following act (c), removing the support body from the pocketof the patch body by directing an outward pulling force applied with thehandle to a location at or in close proximity to an outer periphery ofthe support body to collapse a portion of the support body inwardlytoward the patch body, and (e) withdrawing the deployment device throughthe surgical opening out of the patient.

According to another aspect, a deployment device for a soft tissuerepair prosthesis comprises a self-expanding support body and a handlecoupled to the support body. The support body is to be releasablycoupled to the soft tissue repair prosthesis to assist in spreading thesoft tissue repair prosthesis from a reduced configuration to anexpanded configuration. The support body includes an outer peripheraledge and an opening extending therethrough to facilitate collapse of thesupport body from an expanded configuration to a reduced configuration.The handle includes a distal end coupled to the support body and a freeend extendable away from the support body. The handle is coupled toposition the soft tissue repair prosthesis relative to a soft tissuedefect when the support body is coupled to the soft tissue repairprosthesis and to release the support body from the soft tissue repairprosthesis with a pulling force on the free end of the handle in anoutward direction away from the soft tissue repair prosthesis when thesoft tissue repair prosthesis is in the expanded configuration. Thedistal end of the handle is coupled to the support body to direct thepulling force to the outer peripheral edge of the support body. Thesupport body when coupled to the soft tissue repair prosthesis ismanipulable into the reduced configuration with the soft tissue repairprosthesis for insertion through a surgical opening into a patient.

According to another aspect, a method is provided for repairing a herniadefect. The method comprises an act of: (a) delivering a prosthesis in areduced configuration through a surgical opening into a patient. Theprosthesis includes a patch body and a deployment device. The deploymentdevice includes a self-expanding support body and a handle coupled toand extending away from the support body. The support body is releasablycoupled to the patch body to assist in spreading the patch body to anexpanded configuration. The support body includes an outer peripheraledge and an opening extending therethrough to facilitate collapse of thesupport body for removal through the surgical opening. The methodfurther comprises acts of: (b) following act (a), spreading the patchbody to the expanded configuration via the support body, (c) securingthe patch body in the expanded configuration about the hernia defect,(d) following act (c), removing the support body from the pocket of thepatch body by directing a pulling force applied with the handle to alocation at or in close proximity to the outer peripheral edge of thesupport body to collapse the support body, and (e) withdrawing thedeployment device through the surgical opening out of the patient.

According to another aspect, a deployment device for a soft tissuerepair prosthesis comprises a self-expanding support body and a handlecoupled to the support body. The support body is to be releasablycoupled to the soft tissue repair prosthesis to assist in spreading thesoft tissue repair prosthesis from a reduced configuration to anexpanded configuration. The handle includes a distal end coupled to thesupport body and a free end extendable away from the support body. Thesupport body includes a first support segment and a second supportsegment, the first and second support segments pivotally coupledtogether to collapse the support body from an expanded configuration toa reduced configuration. The handle is coupled to the support body toposition the soft tissue repair prosthesis relative to a soft tissuedefect when the support body is coupled to the soft tissue repairprosthesis and to release the support body from the soft tissue repairprosthesis with a pulling force on the free end of the handle in anoutward direction away from the soft tissue repair prosthesis when thesoft tissue repair prosthesis is in the expanded configuration. Thesupport body when coupled to the soft tissue repair prosthesis ismanipulable into the reduced configuration with the soft tissue repairprosthesis for insertion through a surgical opening into a patient.

According to another aspect, a method is provided for repairing a herniadefect. The method comprises an act of: (a) delivering a prosthesis in areduced configuration through a surgical opening into a patient. Theprosthesis includes a patch body and a deployment device. The deploymentdevice includes a self-expanding support body and a handle coupled toand extending away from the support body. The support body is releasablycoupled to the patch body to assist in spreading the patch body to anexpanded configuration. The support body includes a first supportsegment and a second support segment. The first and second supportsegments are pivotally coupled together to collapse the support body forremoval through the surgical opening. The method further comprises actsof: (b) following act (a), spreading the patch body to the expandedconfiguration via the support body, (c) securing the patch body in theexpanded configuration about the hernia defect, (d) following act (c),collapsing the support body from an expanded configuration to a reducedconfiguration, (e) releasing the collapsed support body from the patchbody, and (f) withdrawing the deployment device through the surgicalopening out of the patient.

According to another aspect, a deployment device for a soft tissuerepair prosthesis comprises a self-expanding support body and a handlecoupled to the support body. The support body is to be releasablycoupled to the soft tissue repair prosthesis to assist in spreading thesoft tissue repair prosthesis from a reduced configuration to anexpanded configuration. The support body is collapsible from an expandedconfiguration to a reduced configuration. The support body includes afirst support segment and a second support segment which are coupledtogether in an alternating overlap arrangement. The handle includes adistal end and a free end opposite the distal end. The distal end of thehandle is coupled to the support body to position the soft tissue repairprosthesis relative to a soft tissue defect when the support body iscoupled to the soft tissue repair prosthesis and to release the supportbody from the soft tissue repair prosthesis with a pulling force on thefree end of the handle in an outward direction away from the soft tissuerepair prosthesis when the soft tissue repair prosthesis is in theexpanded configuration. The support body is manipulable into the reducedconfiguration with the soft tissue repair prosthesis for insertionthrough a surgical opening into a patient.

According to another aspect, a deployment device for a soft tissuerepair prosthesis comprises a self-expanding support body and a handlecoupled to the support body. The support body is to be releasablycoupled to the soft tissue repair prosthesis to assist in spreading thesoft tissue repair prosthesis from a reduced configuration to anexpanded configuration. The support body includes a first supportsegment and a separate second support segment which are coupled togetherto collapse the support body from an expanded configuration to a reducedconfiguration. The first support segment includes a first resilientsupport member and the second support segment includes a secondresilient support member. The first and second support members supportthe support body in the expanded configuration. The handle includes adistal end and a free end opposite the distal end. The distal end of thehandle is coupled to the support body to position the soft tissue repairprosthesis relative to a soft tissue defect when the support body iscoupled to the soft tissue repair prosthesis and to release the supportbody from the soft tissue repair prosthesis with a pulling force on thefree end of the handle in an outward direction away from the soft tissuerepair prosthesis when the soft tissue repair prosthesis is in theexpanded configuration. The support body is manipulable into the reducedconfiguration with the soft tissue repair prosthesis for insertionthrough a surgical opening into a patient.

According to another aspect, a deployment device for a soft tissuerepair prosthesis comprises a self-expanding support body and a handlecoupled to the support body. The support body is to be releasablycoupled to the soft tissue repair prosthesis to assist in spreading thesoft tissue repair prosthesis from a reduced configuration to anexpanded configuration. The support body is collapsible from an expandedconfiguration to a reduced configuration. The handle includes a distalend coupled to the support body and a free end opposite the distal end.The handle further includes an intermediate portion between the distalend and the free end that is releasably securable to the support body toposition the soft tissue repair prosthesis relative to a soft tissuedefect when the support body is coupled to the soft tissue repairprosthesis. The support body is releasable from the soft tissue repairprosthesis with a pulling force on the free end of the handle in anoutward direction away from the soft tissue repair prosthesis when theintermediate portion of the handle is released from the support body andthe soft tissue repair prosthesis is in the expanded configuration. Thesupport body is manipulable into the reduced configuration with the softtissue repair prosthesis for insertion through a surgical opening into apatient.

BRIEF DESCRIPTION OF DRAWINGS

Aspects of the invention are described below, by way of example, withreference to the accompanying drawings in which like numerals referencelike elements, and wherein:

FIG. 1 is an illustration of a prosthesis for repairing a hernia defectwith an assembled hernia repair patch and deployment device in anexpanded configuration;

FIG. 2 is a top view of a hernia repair patch;

FIG. 3 is a bottom view of the hernia repair patch of FIG. 2 ;

FIG. 4 is an illustration of an embodiment of a deployment device;

FIG. 5 is a sectional illustration of an arrangement for coupling thesupport segments of the deployment device taken along line 5-5 of FIG. 4;

FIG. 6A is an exploded sectional view of an arrangement for mounting thehandle of the deployment device taken along line 6-6 of FIG. 4 ;

FIG. 6B is an assembled sectional view of the arrangement for mountingthe handle of the deployment device taken along line 6-6 of FIG. 4 ;

FIG. 7 is an illustration of a deployment device similar to FIG. 5 withthe handle repositioned along the first axis;

FIGS. 8A-8C are illustrations of the prosthesis of FIG. 1 with thedeployment device in various stages of collapse to a non-planarconfiguration for insertion into or withdrawal from the pocket of thehernia repair patch;

FIG. 9 is an illustration of another embodiment of a deployment device;

FIG. 10 is a sectional illustration of an arrangement for coupling thesupport segments of the deployment device taken along line 10-10 of FIG.9 ;

FIG. 11A is an exploded sectional view of an arrangement for mountingthe handle of the deployment device taken along line 11-11 of FIG. 9 ;

FIG. 11B is an assembled sectional view of the arrangement for mountingthe handle of the deployment device taken along line 11-11 of FIG. 9 ;

FIG. 12 is an illustration of a deployment device similar to FIG. 9 withthe handle repositioned along the first axis;

FIG. 13 is an illustration of another embodiment of a deployment device;

FIG. 14 is a sectional illustration of an arrangement for coupling thesupport segments of the deployment device taken along line 14-14 of FIG.13 ;

FIG. 15A is an exploded sectional view of an arrangement for mountingthe handle of the deployment device taken along line 15-15 of FIG. 13 ;

FIG. 15B is an assembled sectional view of the arrangement for mountingthe handle of the deployment device taken along line 15-15 of FIG. 13 ;

FIG. 16 is an illustration of a deployment device similar to FIG. 13with the handle repositioned along the first axis;

FIG. 17 is an illustration of an embodiment of a deployment device;

FIG. 18 is a sectional illustration of an arrangement for coupling thesupport segments of the deployment device taken along line 18-18 of FIG.17 ;

FIG. 19 is a sectional illustration of a hinged handle arrangement takenalong line 19-19 of FIG. 17 ;

FIG. 20 is a partial top view of the handle arrangement of FIG. 19 ;

FIG. 21 is an illustration of a deployment device similar to FIG. 17with the handle repositioned along the first axis;

FIG. 22 is another illustration of a prosthesis for repairing a herniadefect with an assembled hernia repair patch and deployment device in anexpanded configuration;

FIG. 23 is an illustration of another embodiment of a deployment device;

FIG. 24 is an enlarged top view of the support body of the deploymentdevice of FIG. 23 ;

FIG. 25 is a bottom view of the support body of the deployment device ofFIGS. 23-24 ;

FIG. 26 is an illustration of an embodiment of support members for thesupport segments of the deployment device of FIGS. 23-25 ;

FIGS. 27-28 are illustrations of another embodiment of a deploymentdevice with alternating overlap of the support segments;

FIGS. 29-31 are illustrations of another embodiment of a deploymentdevice with alternating overlap of the support segments;

FIG. 32 is an illustration of the prosthesis of FIG. 22 with thedeployment device in a stage of collapse to a reduced configuration forinsertion into or withdrawal from the pocket of the hernia repair patch;

FIG. 33 is an illustration of a deployment device according to anotherembodiment;

FIG. 34 is a bottom view of the deployment device of FIG. 33 ;

FIG. 35 is an illustration of a prosthesis for repairing a hernia defectwith an assembled hernia repair patch of FIG. 2 and deployment device ofFIG. 33 in an expanded configuration;

FIG. 36 is an illustration of the prosthesis of FIG. 35 with thedeployment device collapsed to a reduced configuration for withdrawalfrom the pocket of the hernia repair patch.

FIG. 37 is a top view of another embodiment of a deployment device;

FIG. 38 is a bottom view of the deployment device of FIG. 37 ;

FIG. 39 is an illustration of an embodiment of a support member for thesupport body of the deployment device of FIGS. 37-38 ;

FIG. 40 is an illustration of the deployment device of FIGS. 37-38 beingcollapsed to a reduced configuration during withdrawal from the pocketof a hernia repair patch.

FIG. 41 is an illustration of another embodiment of a deployment device;

FIG. 42 is an enlarged top view of the support body of the deploymentdevice of FIG. 41 ;

FIG. 43 is a bottom view of the support body of the deployment device ofFIGS. 41-42 ;

FIG. 44 is an illustration of an embodiment of a support member for thesupport body of the deployment device of FIGS. 41-43 ;

FIG. 45 is an illustration of another embodiment of a deployment device;

FIG. 46 is an enlarged top view of the support body of the deploymentdevice of FIG. 45 ;

FIG. 47 is a bottom view of the support body of the deployment device ofFIGS. 45-46 ;

FIG. 48 is an illustration of a prosthesis for repairing a hernia defectwith an assembled hernia repair patch and deployment device of FIGS.45-47 in an expanded configuration; and

FIG. 49 is an illustration of the deployment device of FIGS. 45-47 beingcollapsed to a reduced configuration during withdrawal from the pocketof the hernia repair patch.

DETAILED DESCRIPTION

It should be understood that aspects of the invention are describedherein with reference to certain illustrative embodiments and thefigures. The illustrative embodiments described herein are notnecessarily intended to show all aspects of the invention, but ratherare used to describe a few illustrative embodiments. Thus, aspects ofthe invention are not intended to be construed narrowly in view of theillustrative embodiments. In addition, it should be understood thataspects of the invention may be used alone or in any suitablecombination with other aspects of the invention.

Various embodiments are described in connection with the repair of ahernia, specifically a ventral hernia. However, the invention is notnecessarily so limited, and may be employed to repair other types ofhernias, other soft tissue or muscle wall defects, as well as may beused in other surgical or medical treatments. With respect to repair ofa ventral hernia, the repair patch may be placed in the intraperitoneal,preperitoneal, retromuscular, or other anatomical space, as theinvention is not so limited. For ease of understanding, the herniarepair patch is described in connection with an open repair procedurebut may be employed in minimally invasive procedures, or in othertechniques for repairing a hernia or other soft tissue defect as shouldbe apparent to one of skill in the art.

A patch for repairing a hernia may include a patch body having a firstside that will be positioned against a tissue or muscle wall, such asthe abdominal wall, that includes the defect. The first side of thepatch body may be configured for tissue ingrowth. Where the patch willbe located adjacent sensitive organs, such as the intestines or otherviscera, an opposite second side of the patch body may include abarrier, such as a layer of barrier material or a barrier coating, toprevent adhesions between the first side of the patch and the sensitiveorgans. Alternatively, the second side of the patch body may also beconfigured for tissue ingrowth.

The patch body may include a pocket to facilitate positioning and/orfixation of the patch relative to the hernia defect. The pocket may beaccessible through an access opening in the patch body. The patch bodymay include multiple layers of biocompatible material with the pocketformed between adjacent layers. The access opening may be provided inone of the layers forming the pocket. The layer with the access openingmay have, but is not limited to, an annular configuration.

In some open procedures, a hernia repair patch may be reduced in size tofacilitate delivery of the prosthetic device to the treatment site. Forexample, a hernia repair patch may be rolled into a cylindrical shape,or otherwise collapsed into a smaller configuration, suitable forpassage through a surgically created opening, such as an incision. Afterdelivery to the surgical site, the reduced hernia repair patch istransformed into an expanded configuration. The enlarged patch is thenplaced against the abdominal wall and may be fixated by sutures,staples, tacks and/or other fixation elements. For example, fixationelements may be applied through a border region adjacent the outerperipheral edge, and/or at other locations, of the patch into healthytissue surrounding the defect. For some procedures, the patch mayinclude an accessible pocket which extends to the border region. Thefixation elements may be delivered through the pocket and positioned atthe border region for fixation to tissue surrounding the defect. Asurgical instrument, such as a suturing device, stapler or tacker, maybe inserted into the pocket and positioned at desired locations alongthe outer periphery of the pocket to apply a fixation element throughthe border region of the patch.

A deployment device may be employed to position and provisionally holdthe expanded patch against the abdominal wall pending fixation. Thedeployment device may include a support body configured to be releasablycoupled to the patch body. For applications that employ a patch bodywith a pocket, the support body may be configured to be removablyinserted in the pocket of the patch. For applications that employ apatch body without a pocket, one or more releasable fixating componentsmay be employed for releasably connecting the support body to the patchbody. For example, and without limitation, the releasable fixatingcomponents may include a coil-type fixating component located at variouslocations about the support body. The coil-type fixating component mayhave an extended, linear configuration that facilitates passing thefixating component into, and removing the fixating component from, thepatch body and a retracted, coiled configuration which retains the patchbody. Other arrangements for releasably attaching the support body tothe patch body also are contemplated. For example, and withoutlimitation, a suture may run between the support body and the patchbody. The suture can be cut at one or more locations and then thesupport body pulled away from the patch body. Alternatively, the suturemay be sufficiently weak or be modified to include one or more localizedweak points that will fail upon application of a sufficient pullingforce. Alternatively, the support body may be adhered by a relativelyweak adhesive to the patch body. Another option is to configure thesupport body and/or patch body so as to releasably engage each other. Inone such arrangement, the patch body may include one or more slits thatreleasably receive an aspect of the support body.

For applications that employ a patch body with a pocket, the supportbody may have a size and shape that generally corresponds with the sizeand shape of the pocket. Alternatively, the support body may have a sizeand shape that differs from the size and/or shape of the pocket. Forexample, the pocket could be rectangular and the support body oval.Representative shapes of a support body include, but are not limited to,circular, oval or a polygon. In one embodiment, the deployment deviceincludes a generally oval self-expanding support body that is insertableinto a generally oval pocket.

In an expanded configuration, the support body is larger than the accessopening to the pocket and extends across a substantial portion of thepocket to maneuver the patch body into position. In a collapsedconfiguration, the support body may be inserted into or removed from thepocket through the access opening. To reduce movement between thedeployment device and the patch body, the support body may have an outerperipheral edge that is located in close proximity to and generallyfollows the outer periphery of the pocket when the support body isinserted and expanded in the pocket. The support body may be compliantto facilitate its collapsibility when inserted into and removed from thepatch pocket, and when the assembled patch and deployment device arerolled up or otherwise reduced in shape for delivery to the treatmentsite.

The support body may be configured as a shield to help protectunderlying tissue and/or adjacent organs, such as the intestines orother viscera, from unintentional penetration by the fixation elementsduring fixation of the patch about the hernia defect. In this manner,the support body may have a generally planar configuration that is sizedand shaped to occupy a substantial portion of the pocket. When insertedinto the pocket, a surgical instrument may be moved along a surface ofthe support body into position for delivering a fixation element. Thesupport body may be constructed of material that is difficult topenetrate with fixation tools and fixation elements. The material of thesupport body may also have a lubricity that facilitates sliding afixation tool along the surface into position, as well as facilitateinsertion and withdrawal of the support body into and from the patch.

A handle may extend from the support body and be passed through theaccess opening to the pocket of the patch body, if provided, so that afree end of the handle is accessible on the side of the patch bodyfacing the surgical incision. When the assembled patch and deploymentdevice have unfurled or otherwise opened to an expanded shape at thesurgical site, the handle may be drawn through the surgical incision tooutside of the patient. The handle may be manipulated to position anddraw the support body, and the patch body supported by the support body,over the hernia defect and upwardly against the abdominal wall. Thehandle may be adjustable and/or flexible but be sufficiently stiff tocontrol movement and/or allow manipulation of the support body forpositioning the patch relative to the hernia defect. The handle may bepivotal and/or rotatable to various positions relative to the supportbody.

The handle may be arranged to apply a pulling force to one or moreselected regions of the support body. For example, and withoutlimitation, the handle may apply a pulling force to a central region, anouter peripheral region, and end region, or any other region of thesupport body suitable for positioning, manipulating and/or collapsingthe support body as should be apparent to one of skill in the art.

The handle may be releasably attachable to a portion of the support bodyto facilitate movement and/or manipulation of the support body and thepatch. For example, and without limitation, an intermediate portion of ahandle arranged to direct a pulling force to an outer peripheral or endregion of the support body may be configured to be releasably attachedto a central region of the support body. In this manner, when theintermediate portion of the handle is attached to the support body, apulling force on the handle will be directed toward the central regionof the support body to position and/or manipulate the support body andthe patch. When the handle is released, the pulling force on the handlewill be directed toward the outer peripheral or end region of thesupport body to facilitate removal of the support body from the patch.

The deployment device may be provided with one or more features thatassist with collapse of the support body and/or the handle to facilitatecollapsing the deployment device for insertion into and/or removal fromthe pocket. For example, and without limitation, the features may permitportions of the support body and/or the handle to pivot, fold, slideand/or overlap as the deployment device is collapsed to a smallerconfiguration for insertion into and removal from the pocket of thepatch body.

According to one aspect, the support body may include support segmentspivotally coupled together to facilitate collapse of the support bodyfor insertion into and removal from the pocket. The support segments maybe coupled along an overlap region between the segments. An alternatingoverlap arrangement may be employed along the overlap region.

The support body may have a generally planar configuration in theexpanded configuration which may be collapsed to a non-planarconfiguration for insertion into and removal from the pocket. Forexample, and without limitation, the support body may be collapsed to agenerally flattened trapezoidal configuration or a generally conical orfrusto-conical configuration. The support segments may be configured tofold, bend or flex as the segments pivot relative to each other tofurther facilitate collapse of the support body. The segments may fold,bend or flex about a first axis and the segments may pivot about one ormore axes located in a plane that is perpendicular to the first axis.The segments may include one or more reliefs and/or preformed fold linesto facilitate folding or bending.

The handle may be coupled to a region, such as a central region, of thesupport body so that a pulling force on the handle causes the supportbody to collapse into a generally flattened trapezoidal configuration ora generally conical or frusto-conical configuration with portions of thesupport segments overlapping each other, such as a petal-likeconfiguration. The handle may also be configured to fold, bend or flexto facilitate collapsing the deployment device. Such an arrangement mayreduce the pulling force required to release the deployment device fromthe patch body, such as remove it from the pocket of the patch body,with minimal, if any, spraying of bodily fluids as the deployment deviceis withdrawn from the surgical site through the surgical opening.

According to another aspect, the support body may employ a single piecestructure for insertion into and removal from the pocket. The handle maybe arranged to direct a pulling force at or in proximity to an outerperipheral edge at an end of the support body along a first axis. Thehandle may extend from a location outside, at or in proximity to theouter peripheral edge at the end of the support body. Alternatively, thehandle may extend from a location spaced inwardly from the outerperipheral edge. A portion of the handle may extend through the supportbody at a location inwardly from the outer peripheral edge.

The single piece structure may be provided with an opening extendingtherethrough to facilitate collapse of the support body. A radial slitmay extend from the opening to the outer peripheral edge of the supportbody. The slit may extend along a first axis to a first end of thesupport body. The edges of the support body defining the slit maysubstantially abut along the length of the slit to provide asubstantially continuous planar surface across the support body.

A pulling force on the handle causes the support body to collapse from agenerally planar configuration to a non-planar configuration. Forexample, and without limitation, the support body may be collapsed to anon-conical configuration. The handle may be arranged to pull the end ofthe support body outwardly away from the patch body. Alternatively, thehandle may be arranged to draw the end of the support body down orinwardly toward the patch body so as to tuck the end portion below thesupport as it is removed from the patch. If provided with an opening andradial slit, the support body may be collapsed to a non-conicalconfiguration with portions of the support body along the slitoverlapping each other. Such arrangements may reduce the pulling forcerequired to remove the deployment device from the pocket of the patchbody with minimal, if any, spraying of bodily fluids as the deploymentdevice is withdrawn from the surgical site.

A force translation component may be provided to translate the pullingforce from the handle to a region of the support body from the outerperipheral edge at the second end toward a central region of the supportbody or the opening, if provided. The force translation component may belocated along the first axis on a side of the support body opposite thehandle, and may extend from a location outside the peripheral edge to alocation proximate the central region or opening. One or more separategrips may be provided to facilitate positioning the patch body relativeto the hernia defect. The grips may be located in the central region orbetween the opening, if provided, and the second end of the supportbody.

The support body may have a relatively thin, planar shape in theexpanded configuration to facilitate collapsing the patch and deploymentdevice into a reduced size, such as by rolling them into a cylindricalshape, for delivery to the hernia repair site. To assist in unfurlingthe patch into an expanded shape after deployment, the support body mayhave a resiliency or other property (e.g., shape memory) that allows thesupport body to deform from an initial, expanded, shape into a compactconfiguration as the patch is reduced in size for delivery through thesurgical opening, and then return to the initial shape, or at least to ashape larger than the reduced shape, upon reaching the delivery site.Such an ability to revert from a collapsed or reduced configuration toan expanded configuration without requiring assistance of a medicalprofessional is referred to herein as a “self-expanding” support body.Recovery of the support body causes the patch to spread out into anexpanded configuration.

The support body may be formed from one or multiple layers of materialincluding, but not limited to, nylon, polytetrafluoroethylene (PTFE),polyethylene terephthalate glycol (PETG), polypropylene, andpolyethylene. It is also contemplated that the support body may beformed of an elastomeric material including, but not limited to,silicone.

According to one aspect, the support body may include one or moreresilient support members, including frame structures, which permitcollapse of the support body and the patch into a reduced configurationand then assist in expanding the support body and the patch. Theframe(s) may be sandwiched between separate layers of material that formthe support segments of the support body or the single piece structureof the support body. For example, and without limitation, the supportbody may be formed from two layers of nylon material that sandwich asupport frame formed of PETG. The frame(s) may have, but are not limitedto, an annular configuration that extends about and follows the contourof the outer periphery of the support segments or the support body.

According to another aspect, the support body may be formed of amaterial that alone provides a desired balance of flexibility, stiffnessand resilience for allowing the support body to be collapsed andexpanded while providing support for the patch. For example, and withoutlimitation, the support body may include a laminated sheet formed frommultiple layers of PTFE material. The number, thickness and/ororientation of individual layers relative to each other may be selectedto provide the laminated sheet with desired properties for flexibility,stiffness and/or resilience.

The support body may be characterized by its positioning relative to theaxes of the patch body. For example, the support body may include a topportion that is positionable on an upper portion of the patch bodyrelative to a first axis, and a bottom portion that is positionable onan opposite, lower portion of the patch body relative to the first axis.Each of the top portion and the bottom portion of the support body mayhave a curved profile, although straight, compound straight, angledand/or curved, and other profiles are contemplated as should be apparentto one of skill in the art. The support body may include lateral andmedial portions which may have similar or different profiles as comparedto the top and bottom portions.

With the patch body spread out over the hernia defect, and secured tothe tissue or muscle wall, the inventors have recognized that there nolonger is need for the deployment device. Accordingly, the support body,as observed earlier, may be releasably coupled to the hernia repairpatch, such as by being removably inserted in a pocket of the herniarepair patch, allowing selective removal of the deployment device by thesurgical team after expanding, positioning, and/or fixation of the patchbody. Removal of the support body from the pocket of the patch will, inturn, separate the deployment device from the fixated patch body. Thedetached deployment device may then be removed from the patient, such asby withdrawal through the same opening in which the patch and deploymentdevice had been delivered into the patient. Withdrawal may befacilitated by collapsing the support body and/or portions of the handleat one or more regions and pulling a free end of the handle to draw thesupport body and handle into a collapsed configuration that may readilypass through the opening used for delivering the patch and deploymentdevice. The support body and/or handle may be configured and arranged toreduce the pulling force required to remove the deployment device fromthe pocket of the patch body with minimal, if any, spraying of bodilyfluids as the deployment device is withdrawn from the surgical sitethrough the surgical opening.

As shown in FIGS. 1-3 , a prosthesis 20 for repairing a hernia or othersoft tissue defect may include a patch body 22 having a first surface 24configured to face the hernia defect and a second surface configured toface away from the hernia defect. The first surface 24 may be arrangedfor tissue ingrowth, and may include one or more tissue infiltratablelayers such as a mesh or other porous fabric amenable to tissueingrowth. The second surface 26 may also be arranged for tissueingrowth, and may include a tissue infiltratable layer such as a mesh orother porous fabric amenable to tissue ingrowth. Alternatively, thesecond surface may be configured as a barrier to adhesions between thefirst surface and sensitive organs or tissue, such as the intestines orother viscera. The second surface may be a solid or substantiallynon-porous barrier layer or a barrier coating that will prevent contactbetween the viscera and the porous tissue ingrowth fabric. As shown inFIG. 2 , the patch body 22 may be defined by a first axis 28 and asecond axis 30 that is substantially perpendicular to the first axis.The intersection of the first and second axes may coincide with acenter, or approximate center 32, of the patch body.

In one embodiment, the patch body may include a pocket 34 and an accessopening 36 to the pocket to facilitate positioning and securement of thepatch body 22 relative to a hernia defect. The pocket may be locatedbetween the first and second surfaces of the patch body. In oneembodiment, the pocket 34 may be formed with a first layer 38 and asecond layer 40 of biocompatible material connected to each other, suchas by stitching or welding, at or proximate to the outer peripheral edge42 of the patch body. The outer periphery 44 of the pocket may be inclose proximity to and extend along the connection between the layers.The access opening 36 may be provided in the first layer 38 and have,but is not limited to, a shape that generally corresponds to the outerperipheral edge of the patch body. In this manner, the first layer mayhave, but is not limited to, an annular configuration. Alternativearrangements for forming the pocket are contemplated as should beapparent to one of skill in the art. For example, and withoutlimitation, the pocket may be formed with a single layer of material inwhich the outer peripheral region of the layer is folded over the mainportion of the material and secured to form the pocket between the mainlayer and the fold.

The first and second layers 38, 40 forming the pocket may be tissueinfiltratable layers such as a mesh or other porous fabric amenable totissue ingrowth to ensure tissue ingrowth across the entire firstsurface 24 of the patch body. In this manner, at least those portions ofthe second layer 26 exposed by the access opening 36, if not the entiresecond layer, would also be amenable to tissue ingrowth. If desired, athird layer (not shown) or coating may be provided over the surface ofthe second layer opposite the first layer as a barrier to adhesionsbetween the first surface and sensitive organs or tissue. Alternativearrangements of a patch body are contemplated as should be apparent toone of skill in the art. For example, and without limitation, the patchbody may include only tissue infiltratable layers, only solid ornon-tissue infiltratable layers, or a combination of tissueinfiltratable and non-tissue infiltratable aspects situated in the samelayer. The patch body may also be configured without a pocket and/oraccess opening to a pocket.

A deployment device may be employed to position and provisionally holdthe expanded patch against the abdominal wall pending fixation. Thedeployment device may be configured to be releasably coupled to thepatch body. In one embodiment as shown in FIG. 1 , the deployment device50 may be placed within the pocket 34 of the patch body. However, otherarrangements are contemplated for coupling the deployment device to thepatch body, particularly for a patch body without a pocket. For example,and without limitation, the deployment device may include releasablefixating components for releasably connecting the deployment device tothe patch body.

In one illustrative embodiment, the deployment device 50 may include asupport body 52 that is removably insertable in the pocket 34 of thepatch. A handle 54 may extend from the support body and through theaccess opening 36 when placed in the pocket. During a repair procedure,the handle 54 may be drawn through an opening, such as a surgicalincision in the abdominal wall, to outside of the patient. A pullingforce on the free end of the handle in an outward direction away fromthe support body 52 and the associated patch body 22 hoists the supportbody and patch body against the abdominal wall. The handle may also beused to maneuver the patch body into a desired positon relative to ahernia defect. As illustrated, the handle may extend from a centralregion of the support body. However, it is to be appreciated that thehandle may extend from other regions of the support body suitable formanipulating, positioning and/or holding the patch against the abdominalwall, and thereafter separating the deployment device from the patchbody.

The support body 52 may have a thin or reduced profile and, for exampleand without limitation, may be in the form of a flat sheet or sheets soas to minimize the overall thickness of the patch when assembled withthe deployment device and reduced for delivery through the opening tothe treatment site. The support body may be a continuous component ormay include two or more discrete segments that are contiguous and/orspaced from each other which in combination form the support body.

The support body may have a size and shape that generally correspondswith the size and shape of the pocket. In an expanded configuration, thesupport body is larger than the access opening to the pocket andoccupies a substantial portion of the pocket to facilitate maneuveringthe patch body into position. In a collapsed or smaller configuration,the support body may be inserted into or removed from the pocket throughthe access opening.

To reduce movement between the deployment device and the patch body, thesupport body 52 may have an outer peripheral edge 56 that is located inclose proximity to and generally follows the outer periphery 44 of thepocket when the support body is inserted and expanded in the pocket. Thesupport body may be compliant to facilitate its collapsibility wheninserted into and removed from the patch pocket, and when the assembledpatch and deployment device are rolled up or otherwise reduced in shapefor delivery to the treatment site.

In one illustrative embodiment, the support body 52 may have a planarconfiguration in the expanded configuration. As shown in FIG. 4 , thesupport body may be defined by a first axis 58 and a second axis 60 thatis substantially perpendicular to the first axis. The intersection ofthe first and second axes may coincide with a center 62, or approximatecenter, of the support body. An opening 64 may be located at theapproximate center of the support body to facilitate its collapse to asmaller collapsed configuration for insertion into and withdrawal fromthe pocket of the patch.

In one illustrative embodiment shown in FIGS. 4-7 , the support body 52may include a first support segment 66 and a second support segment 68movably coupled to each other to facilitate collapse of the support bodyto a non-planar configuration. In one embodiment, the first and secondsupport segments may be coupled with a pair of hinges 70 which allow thesegments to rotate relative to each other as the support body iscollapsed for insertion into or withdrawal from the pocket and as thesupport body returns to the expanded configuration. The hinges 70 may belocated along the second axis 60 on opposite sides of the first axis 58.As shown, portions of the support segments connected together mayoverlap each other and form an overlap region along the second axis.Each hinge 70 may be formed using a fastener, such as a rivet, screw,post or pin, or other suitable arrangement as should be apparent to oneof skill in the art.

With the support body in the expanded, planar configuration, each hingeaxis 72 extends in a direction perpendicular to a plane defined by thefirst and second axes 58, 60. To facilitate collapse of the supportbody, the first and second segments 66, 68 may be configured to bend,fold or flex about the first axis 58. This allows the positions of thehinges 70 to similarly move about the first axis as the support body iscollapsed, thereby changing the orientation of the hinge axes 72 toextend in a direction more aligned with the second axis 60 to facilitaterotation of the segments relative to each other. In this manner, thehinges may move within a plane extending along the second axis 60 andperpendicular to the first axis 58 for rotation of the support segments.

Each support segment 58, 60 may include one or more features tofacilitate bending, folding or flexing about the first axis. In oneembodiment, each support segment may include a relief 74 located alongthe first axis 58 at the outer peripheral edge 56 of the support bodyand the inner peripheral edge 76 of the opening 64. The reliefs 74 maybe configured to ease stress along the peripheral edges and promotebending, folding or flexing along the first axis. As shown, each reliefmay include a notch extending inwardly from the peripheral edge,although any suitable relief may be employed as should be apparent toone of skill.

For some applications, each support segment may include a preformedweakened region extending between the reliefs, or in lieu of reliefs, topromote bending, folding or flexing along the first axis. For example,the support segments may be formed from a material that, althoughsufficiently flexible for rolling the support body into a cylindricalshape, may nevertheless be difficult to bend, fold or flex about thefirst axis while pivoting the support segments about the hinges.

In one illustrative embodiment, the weakened region may include a seriesof spaced perforations 78 located along the first axis 58 that form afold line for collapsing the support segments. For example, and withoutlimitation, the perforations 78 may include circular holes, non-circularholes and/or elongated slots. However, the weakened region may employany suitable arrangement that allows the support segment to bend, foldor flex about the first axis. For example, and without limitation, theweakened region may employ relatively weak or thin material as comparedto adjacent material, and/or employ one or more score lines which permitbending, folding or flexing along the region.

In one embodiment, the handle 54 may include a handle base 80 that isattached to the support body and a handle pull 82 that extends from thehandle base. The handle base 80 may be located along the second axis 60and bridge across the first axis 58 and/or the opening 64 in the supportbody. As illustrated, the handle base may be located on a first side ofthe support body so that a pulling force on the handle pull in adirection extending away from the opposite second side of the supportbody is translated to the support body by the handle base in a directiontoward the first side of the support body.

The handle base 80 may be configured to support and connect the supportsegments 66, 68 together. In one embodiment, the handle base may includea pair of fasteners 84 located on opposite sides of the first axis 58and along the second axis 60. The fasteners may extend through holes 86in the support segments to couple the segments together with the handlebase. The fasteners 84 may be configured to form the hinges for thesupport segments. In one embodiment, the support segments may be mountedto fasteners, such as posts, protruding from opposite end portions ofthe handle base and secured with a collar 88 that snaps over a free endof each post. However, any fastening arrangement suitable for couplingthe support segments to the handle base may be employed as should beapparent to one of skill in the art.

The handle pull 82 may be pivotal and/or rotatable relative to thehandle base 80. A shown in FIGS. 4 and 7 , the handle pull 82 may bearranged to pivot toward and away from the support body along the firstaxis 58 and/or the second axis 60 to facilitate collapsing thedeployment device with the associated patch body and positioning thehandle pull for manipulation and/or withdrawal of the support body fromthe patch body. For example, and without limitation, the handle pull maybe positioned along the first axis 58 and pivoted toward and in closeproximity to the support body to allow the deployment device andassociated patch to be rolled into a reduced cylindrical shape along thefirst axis for delivery to the treatment site through the surgicalopening. After deployment, the handle pull may be pulled away from thesupport body and through the surgical opening with the handle pullpositioned along the first axis. Alternatively, the handle pull may bearranged along the second axis 60, or in any desired position betweenthe first and second axes. If desired, the handle pull 82 may berotatably mounted to the handle base 80 to permit rotation of the handlepull to any suitable position relative to the first and second axes. Forexample, the handle pull may be repositioned along the second axis 60,or repositioned in any desired position between the first and secondaxes.

As shown in FIGS. 4 and 6A-6B, the handle pull 82 may have an elongatedconfiguration with a mount component 90 for mounting the handle pull tothe handle base and a grip component 92 extending from the mountcomponent for manipulating the support body and associated patch body.The grip component 92 may be pivotally coupled to the mount component 90to allow the grip component to pivot toward and away from the supportbody. In one embodiment, the handle pull 82 may include a hinge 94 whichcouples the grip component to the mount component. In one embodiment,the hinge may be a living hinge integrally formed with the handle pull,although other arrangements for coupling the grip component to the mountcomponent may be employed as should be apparent to one of skill in theart.

As indicated above, the handle pull 82 may be rotatably mounted to thehandle base 80 so that the handle pull may be positioned along the firstaxis 58 and the second axis 60, as well as positions between the firstand second axes, if desired. In one embodiment, the mount component 90may be rotatably mounted to a central portion of the handle base 80about a third axis 96 located at the approximate center of the supportbody and perpendicular to the first and second axes. Similar to thesupport segments, the mount component may be mounted to a fastener 84,such as a post, protruding from a central portion 98 of the handle baseand secured with a collar 88 that snaps over a free end of the post.However, any fastening arrangement suitable for rotatably mounting thehandle pull to the handle base may be employed as should be apparent toone of skill in the art.

For some applications, the handle base 80 may be sufficiently stiff tomanipulate the support body and associated patch body in the extendedconfiguration at the treatment site, as well as translate a pullingforce from the handle pull 82 to collapse and withdraw the support bodyfrom the patch and treatment site. To ensure adequate collapsibility ofthe deployment device for insertion into and withdrawal from the patchbody and treatment site, the handle base 80 may be configured to bend,fold and/or flex at one or more predetermined regions. For example, thehandle base may be provided with one or more weakened regions of reducedstiffness. In one embodiment shown in FIGS. 6A-6B, the handle base 80may include a pair of hinges 100 which couple the central portion 98 tothe end portions 102 at opposite sides of the central portion. Eachhinge 100 may be oriented in a direction parallel to the first axis 58to facilitate rolling, folding, bending and flexing of the deploymentdevice about the first axis. Each hinge 100 may be a living hingeintegrally formed with the handle base, although other arrangements maybe employed as should be apparent to one of skill in the art.

For some applications, it may be desirable retain the handle pull 82 inone or more selected positions. For example, and without limitation, thehandle may be configured to retain the handle pull 82 in positions alongthe first axis 58, the second axis 60 and/or positions between the firstand second axes. In one embodiment shown in FIGS. 6A-6B, the handle mayinclude a detent 103 between the handle pull 82 and the handle base 80that is configured to hold the handle pull in position when rotated toextend along the first axis and/or the second axis. In one embodiment,the detent may include the hinge 94 of the handle pull 82 beingconfigured to coact with a side edge 104 of the handle base to retainthe handle pull in a first position along the first axis, and to coactwith a hinge 100 of the handle base to retain the handle pull in asecond position along the second axis. Other arrangements suitable forretaining the handle pull in a selected position may also be employed asshould be apparent to one of skill in the art.

As illustrated in FIGS. 8A-8B, a pulling force F on the handle 54encourages the support segments 66, 68 to rotate about the hinges 70 andfold about the first axis to collapse the support body into a collapsedconfiguration having a reduced size relative to the access opening topermit withdrawal of the support body from the pocket of the patch body.In one illustrative embodiment, the support segments rotate toward eachother with the second support segment 68 folding and rotating within thefirst support segment which similarly folds and rotates over the secondsupport segment. In this manner, portions of the first and secondsupport segments overlap each other in the collapsed configuration, forexample, in a petal-like arrangement. As illustrated in FIG. 8C, thesupport segments may be configured to collapse the support body into agenerally flattened, non-planar configuration having a generallytrapezoidal shape. In this regard, the inner peripheral edge 76 of theopening and the outer peripheral edge 56 of the support body generallydefine the bases of the trapezoidal shape and the fold lines of thesupport segments extending along the first axis 58 generally define thenonparallel legs of the trapezoidal shape. Such an arrangement mayreduce the pulling force required to remove the deployment device fromthe pocket of the patch body with minimal, if any, spraying of bodilyfluids resulting from withdrawal of the deployment device from thesurgical site.

FIGS. 9-32 illustrate additional embodiments of a deployment device 50to position and provisionally hold an expanded patch against theabdominal wall pending fixation. Each deployment device 50 may include asupport body 52 formed with first and second support segments 66, 68coupled together and may implement one or more of the features tofacilitate collapse of the support body, as described above. Eachdeployment device may employ a different handle arrangement, asdescribed below.

In an illustrative embodiment shown in FIGS. 9-12 , the support segments66, 68 and the handle pull 82 may be coupled to the handle base 80 usingkeyhole fastening arrangements. The handle base 80 may include afastener 84, such as a post, at the central portion for mounting thehandle pull and a fastening post 84 at each end portion for coupling thesupport segments.

The support segments 66, 68 may include a keyhole opening 110 thatcooperates with each post 84 on the end portions 102 of the handle base80 to couple the support segments to the base. Each post 84 includes anenlarged head 112 that is sized to pass through the enlarged end 114 ofthe keyhole but not pass through the small end 116 of the keyhole. Asshown, the keyholes 110 in the support segments are arranged to extendalong the second axis 60 with the enlarged end of the keyhole locatedcloser toward the outer periphery of the support body. The keyholes 110may be positioned so that flexing the support segments about the firstaxis 58 reduces the spacing between the keyholes to allow passage ofeach post 84 through the large end 114 of the corresponding keyhole. Asthe flex in the support segments is released, the spacing between thekeyholes increases thereby positioning each post 84 in the small end 116of its corresponding keyhole.

The handle base 80 may include tabs 120 with a keyhole opening 122 thatcooperates with the posts 84 to secure the support segments to thehandle base. As shown in FIG. 10 , the keyholes 122 in the tabs arearranged to extend along the second axis 60 with the enlarged end of thekeyhole located closer toward the central portion of the support body.In this manner, the tab keyholes 122 employ an orientation opposite tothe keyholes 110 in the support segments and work together to secure thesupport segments to the handle base during collapse and expansion of thesupport body. As shown, the tabs 120 may be flexibly coupled to the endportions 102 of the handle base.

The handle pull 82 may be mounted to the center portion of the handlebase 80 in a similar manner. As shown in FIGS. 11A-11B, the mountcomponent 90 of the handle pull may include an opening 124 that receivesthe post 84 extending from the central portion 98 of the handle base. Atab 120 with a keyhole opening 122 extends from the side edge 104 of thecentral portion to lock the mount component on the post. The handle pullmay be rotated about the post to position it along the first or secondaxes, as desired.

In an illustrative embodiment shown in FIGS. 13-16 , the supportsegments may be coupled to the handle base using a snap-fit fasteningarrangement. The handle base 80 may include a post 84 at each endportion 102 for coupling the support segments. The support segments mayinclude an opening 130 configured to snap onto each post on the endportions of the handle base to couple the support segments to the base.As shown in FIG. 14 , each post includes an enlarged head 112 that issized to be pressed through the corresponding opening 130 in the supportsegment. As shown, the openings 130 in the support segments may employ afan finger arrangement in which inwardly extending fingers 132 aroundthe opening are configured to flex over the enlarged head 112 of thepost and then return to their initial non-flexed state below the posthead to secure the support segments to the handle base.

The handle pull 82 may be pivotally mounted to the handle base 80 usinga ball and socket arrangement. In one embodiment, the mount component 90of the handle pull may be configured as a ball 134 and the centralportion of the handle base 80 may include a socket 136 configured toreceive the ball of the mount component. As shown in FIGS. 15A-15B, thehandle pull 82 may be assembled to the handle base 80 by inserting thegrip component 92 through the socket 136 so that the ball 134 isreceived in and held by the socket. The socket 136 may include one ormore slots 138 configured to allow passage of the grip component throughthe socket while capturing the ball of the mount component therein. Inone embodiment, the socket 136 may include slots 138 along the firstaxis 58 and the second axis 60 of the deployment device to allow thehandle pull to be pivoted along these axes.

In an illustrative embodiment shown in FIGS. 17-21 , the supportsegments 66, 68 may be coupled to the handle base 80 using a snap-fitfastening arrangement. The handle base may include a fastener 140, suchas a post, at each end portion for coupling the support segments. Asshown in FIG. 18 , the support segments may include an opening 142configured to snap onto each post on the end portions of the handle baseto couple the support segments to the base. Each fastening post 140 mayemploy a resilient post arrangement with an enlarged head 144 that issized to be pressed through the corresponding opening in the supportsegment. As shown, each post 140 may include a pair of spaced resilientfingers 146 configured to flex toward each other to pass through theopenings as the support segments are pressed onto the post. Afterpassage through the openings, the fingers 146 spring back to theirinitial non-flexed state so that the post head 144 secures the supportsegments to the handle base.

The handle pull 82 may be pivotally mounted to the handle base 80 usinga flexible hinge arrangement. In one embodiment, the mount component 90of the handle pull may be configured to permit the grip component 92 tobe pivoted, for example, by folding, to extend along the first andsecond axes. As shown in FIGS. 19-20 , the mount component may include,but is not limited to, a pair of hinges 148 having different angularorientations α₁, α₂ relative to each other with the mount component 90having an angular orientation Θ relative to the first and second axes58, 60 conducive to folding the grip component along each axis.

In one embodiment, the handle 54 may employ a unitary structure with thehandle pull 82 integrally formed with the handle base 80. The hinges 148may include living hinges integrally formed with the mount component.The mount component 90 may be oriented at an angle Θ of approximately 45degrees to the first and second axes, and the hinges 148 may be orientedat angles α₁ of approximately 23 degrees and α₂ of approximately 35degrees relative to the plane defined by the first and second axes 58,60. Other hinge arrangements are contemplated as should be apparent toone of skill in the art.

In illustrative embodiments shown in FIGS. 22-32 , the handle pull 82may be integrally formed with the handle base 80 as a single structure.The handle base may include a pair of mounting segments 83 located onopposite sides of the first axis 58 and along the second axis 60.Fasteners 84 may extend through holes 86 (FIG. 26 ) in the supportsegments to couple the support segments together with the handle base.The fasteners 84 may be configured to form the hinges for the supportsegments. In one embodiment, the support segments may be coupled to thehandle base with individual fasteners that extend through holes (notshown) in the mounting segments of the handle base and secured with acollar 88 (FIG. 25 ) that snaps over a free end of each fastener.

The handle base 80 may include a pair of connector segments 99 whichcouple a central portion 98 of the base to the mounting segments 83 atopposite sides of the central portion. Each connector segment 99 may beoriented in a direction along the second axis 60 and be sufficientlyflexible to facilitate rolling, folding, bending and flexing of thedeployment device about the first axis. Each connector segment 99 may beintegrally formed with the handle base, although other arrangements maybe employed as should be apparent to one of skill in the art.

As indicated above, the support segments 66, 68 may be configured toroll, bend, fold or flex to facilitate collapse of the support body forinsertion into and withdrawal from the pocket of the patch, as well asrolling of the patch and support body for delivery to a surgical site.The support segments may also have a sufficient amount of resilience toreturn to an expanded or open configuration to expand and support thepatch after delivery for placement at the surgical site.

In one embodiment, each support segment 66, 68 may include a resilientsupport member to help deploy the support body, and thereby the patch,into an expanded configuration, such as a planar configuration. Asillustrated in FIGS. 23-28 , the resilient support member 101 mayinclude a continuous loop or ring that extends along the outer margin ofthe support segment. As shown, the support member 101 may be positionedat the outer peripheral edge 56 of the support segment. However, thesupport member may be spaced inwardly from the outer peripheral edgeand/or at discrete locations throughout the body of the support segmentas should be apparent to one of skill in the art.

As illustrated, each support member 101 may have an annularconfiguration of a desired width and thickness to provide a desireddegree of resilience or rigidity. Each support member may have agenerally D-shape configuration that corresponds to the shape of thesupport segments. Each support member may include a curved outer portion103 and a center portion 105 that connects the ends of the outerportion. As shown, the center portion 105 may have an undulatingconfiguration that facilitates collapse and expansion of the supportbody. However, the support member may have any suitable shape and/orcross section as should be apparent to one of skill in the art.

Rather than using a separate support member, it may be desirable toconstruct each support segment from a single sheet of material thatalone provides the desired amount of flexibility, foldability,rollability, resiliency and support. Such an arrangement may reducecosts associated with fabricating the support segments.

As shown in FIGS. 29-31 , each support segment 66, 68 may be formed froma sheet of material that alone provides a desired balance offlexibility, stiffness and resilience for allowing the support body tobe collapsed and expanded while providing support for the patch. Forexample and without limitation, each support segment may be fabricatedfrom a sheet of plastic material that provides the support body with thedesired support properties, as well as other properties including, butnot limited to, strength and/or stress crack resistance.

As described above, portions of the support segments 66, 68 connectedtogether may overlap each other and form an overlap region along thesecond axis 60. In one embodiment as shown in FIGS. 23-25 , the firstsupport segment 66 may overlap the same side of the second supportmember 68 along the entire length of the overlap region. In anotherembodiment as shown in FIGS. 27-31 , the overlap between the first andsecond support segments may alternate along the length of the overlapregion. As shown, the first support segment may overlap one side of thesecond support segment along a portion of the overlap region above thefirst axis and may overlap the opposite side of the second supportsegment along a portion of the overlap region below the first axis. Analternating overlap arrangement between the first and second supportsegments may provide less contact or obstruction between the supportsegments when collapsed for withdrawal from the patch and/or may reducethe profile of the collapsed support body. It is to be appreciated thatany suitable overlap arrangement, if desired, may be used between thesupport segments as should be apparent to one of skill in the art.

As illustrated in FIG. 32 , a pulling force F on the handle 54encourages the support segments 66, 68 to rotate about the hinges 70 andfold about the first axis to collapse the support body into a collapsedconfiguration having a reduced size relative to the access opening topermit withdrawal of the support body from the pocket of the patch body.

In an illustrative embodiment associated with the deployment device ofFIGS. 23-25 , the support segments 66, 68 rotate toward each other withthe second support segment 68 folding and rotating within the firstsupport segment 66 which similarly folds and rotates over the secondsupport segment.

In an illustrative embodiment associated with the deployment devices ofFIGS. 27-31 , the support segments 66, 68 rotate toward each other witha first portion of the second support segment 68 folding and rotatingwithin a first portion of the first support segment 66 which similarlyfolds and rotates over the first portion of the second support segment,and with a second portion of the first support segment 66 folding androtating within a second portion of the second support segment 68 whichsimilarly folds and rotates over the second portion of the first supportsegment.

In each arrangement, portions of the first and second support segmentsoverlap each other in the collapsed configuration, for example, in apetal-like arrangement. However, it is to be appreciated that thesupport segments may be configured to collapse in any suitablearrangement as should be apparent to one of skill in the art.

As illustrated in FIG. 32 , the support segments 66, 68 may beconfigured to collapse the support body into a generally conical orfrusto-conical configuration. As described above, the support segmentsmay be configured to collapse the support body into a generallyflattened, non-planar configuration having a generally trapezoidalshape. In this regard, the inner peripheral edge of the support segmentsand the outer peripheral edge 56 of the support body generally definethe bases of the trapezoidal shape and the fold or bend lines of thesupport segments extending along the first axis 58 generally define thenonparallel legs of the trapezoidal shape. Such arrangements may reducethe pulling force required to remove the deployment device from thepocket of the patch body with minimal, if any, spraying of bodily fluidsresulting from withdrawal of the deployment device from the surgicalsite.

In alternate embodiments illustrated in FIGS. 33-49 , the deploymentdevice 50 may include a support body 52 employing a single piecestructure for insertion into the pocket of the prosthesis. The supportbody 52 may include a first portion 152 and a second portion 154 onopposite sides of the second axis 60.

A handle 54 may be coupled to the second portion 154 and arranged todirect a pulling force to the outer peripheral edge 56 at a second end162 of the support body opposite the first end 156 along the first axis58. In one embodiment, the handle 54 may extend from a location outsidethe outer peripheral edge at the second end of the support body. Asshown, the handle may be arranged to extend along the first axis.

In one embodiment illustrated in FIGS. 33-36 , an opening 64 may extendthrough the support body to facilitate collapse of the support body forinsertion into and removal from the pocket. A radial slit 150 may extendfrom the opening to the outer peripheral edge 56 of the support body. Asshown, the opening 64 may be located at the approximate center of thesupport body. The slit 150 may be located on the first portion 152 ofthe support body and extend along the first axis 58 from the opening toa first end 156 of the support body. The first portion may include firstand second segments 158, 160 on opposite sides of the first axis 58.Edges of the first and second segments defining the slit maysubstantially abut along the length of the slit to provide asubstantially continuous planar surface across the first and secondsegments. It is to be appreciated that the size and/or location of theopening and/or slit may be chosen to provide the support body with adesired collapsibility as should be apparent to one of skill in the art.It is also to be appreciated that the an opening and/or slit are notnecessary and may be omitted from the support body.

Applying a pulling force F on the handle, as illustrated in FIG. 36 ,encourages the support body to pivot and fold into a reducedconfiguration, such as non-planar configuration, with portions of thefirst and second segments 158, 160 of the support body overlapping eachother. As illustrated, pulling the handle in an outward direction awayfrom the patch body draws the second end 162 of the support body awayfrom the patch body. Directing the pulling force toward the outerperipheral edge at the second end of the support body causes at least asegment of the second portion to lift and pivot about a region generallyparallel to the second axis 60 while also folding about the first axis58 as the support body is withdrawn through the access opening of thepocket. Such an arrangement may reduce the pulling force required toremove the deployment device from the pocket of the patch body withminimal, if any, spraying of bodily fluids resulting from the deploymentdevice being withdrawn from the surgical site.

A force translation component may be provided to translate the pullingforce across a region of the support body from the outer peripheral edgeat the second end toward the opening. As shown in FIG. 34 , the forcetranslation component 170 may be located along the first axis 58adjacent a first side of the support body opposite the handle 54 so thata pulling force on the handle is applied in an outward direction awayfrom an opposite second side of the support body and against the firstside of the support body. The force translation component 170 may havean elongated configuration extending from a location proximate theopening 64 to a location adjacent the peripheral edge 56. The forcetranslation component may be attached to the support body usingfasteners 172, including as rivets or screws, or otherwise secured, suchas by welding or bonding with an adhesive, as should be apparent to oneof skill in the art.

The handle 54 may extend from an end 174 of the force translationcomponent 170 extending beyond the outer peripheral edge 56 at thesecond end 162 of the support body. The handle 54 and the forcetranslation component 170 may be integrally formed as a single structurewith an integral hinge 176, such as a living hinge, or other pivotingfeature coupling the handle to the force translation component.Alternatively, the handle and force translation component may beseparately fabricated components coupled together with a separate hingeor otherwise fastened to each other using any suitable arrangement asshould be apparent to one of skill in the art.

An arrangement having the handle extending from a location adjacent theouter peripheral edge of the support body may potentially renderpositioning and/or manipulation of the support body with the handledifficult, if not ineffective. To facilitate positioning the patch bodyrelative to the hernia defect, the deployment device may include one ormore grips 180 extendable away from the support body.

Each grip 180 may have a size and/or configuration conducive for beinggrasped and manipulated by hand and/or surgical tool. Each grip mayinclude one or more features configured to enhance a surgeon’s abilityto grasp and manipulate the deployment device and associated patch bodyinto position at the treatment site. As shown, each grip 180 may includea hole 182 extending therethrough to enhance the ability to grasp thegrip. Additionally or alternatively, other grip features may be employedas should be apparent to one of skill in the art.

Each grip 180 may be movable relative to the support body to facilitatemanipulation of the patch body and the support body into the reducedconfiguration for insertion through a surgical opening into a patient.For example, and without limitation, each grip may be foldable, pivotalor flexible relative to the support body.

Each grip may 180 be located on the second portion 154 between theopening 64 and the second end 162 of the support body. As shown, a pairof grips 180 may be located on opposite sides of the first axis 58. Inone embodiment, the grips may be coupled to an end 184 of the forcetranslation component opposite the handle and extend through the supportbody. The grips and the force translation component may be integrallyformed as a single structure with an integral hinge 186, such as aliving hinge, or other pivoting feature coupling the grips to the forcetranslation component. Alternatively, the grips and force translationcomponent may be separately fabricated components coupled together witha separate hinge or otherwise fastened to each other using any suitablearrangement as should be apparent to one of skill in the art.

In one embodiment as shown in FIGS. 37-40 , the handle 54 may include ahandle pull 169 that extends from a location outside the outerperipheral edge at the second end of the support body. The handle 54 mayinclude a handle base 170 for mounting the handle pull 169 to thesupport body. The handle base may be configured as a force translationcomponent to translate the pulling force across a region of the supportbody from the outer peripheral edge at the second end 162 toward thesecond axis 60 of the support body. As shown in FIG. 38 , the handlebase 170 may be located along the first axis 58 adjacent the second sideof the support body opposite the handle 54 so that a pulling force onthe handle is applied in an outward direction away from the first sideof the support body and against the second side of the support body. Thehandle base 170 may have an elongated configuration extending from alocation proximate the second axis 60 to a location adjacent theperipheral edge 56. The handle base may be attached to the support bodyusing fasteners 172, including rivets or screws, or otherwise secured,such as by welding or bonding with an adhesive, as should be apparent toone of skill in the art.

The handle pull 169 may extend from an end 174 of the handle base 170extending beyond the outer peripheral edge 56 at the second end 162 ofthe support body. The handle pull 169 and the handle base 170 may beintegrally formed as a single structure with an integral hinge 176, suchas a living hinge, or other pivoting feature coupling the handle pull tothe handle base. Alternatively, the handle pull and the handle base maybe separately fabricated components coupled together with a separatehinge or otherwise fastened to each other using any suitable arrangementas should be apparent to one of skill in the art.

An arrangement having the handle extending from a location adjacent theouter peripheral edge of the support body may potentially renderpositioning and/or manipulation of the support body with the handledifficult. Thus, the deployment device may include one or more featuresto facilitate manipulation and/or positioning of the patch body relativeto the hernia defect.

In one embodiment illustrated in FIGS. 37-38 , the deployment device mayinclude a handle fastening arrangement that releasably secures a portionof the handle to the support body at a location that provides sufficientleverage for manipulating and/or positioning the support body and thepatch. As shown, the handle pull 169 may include a keyhole opening 171that is configured to cooperate with the fastener 172 located inproximity to the second axis 60 for attaching the handle base to thesupport body. In this manner, the handle is effectively coupled to thecentral region of the support body when the keyhole opening is placedover the fastener such that forces applied with the handle will betransferred to the central region of the support body. When the patchhas been positioned, the handle pull 169 may be pulled to release thefastener 172 from the keyhole opening 171 so that the handle can then belifted and used to withdraw the support body from the patch by applyingforce at the second end 162 of the support body, as described above.

Additionally or alternatively, the deployment device may include one ormore grips 180 extendable away from the support body. Each grip 180 mayhave a size and/or configuration conducive for being grasped andmanipulated by hand and/or surgical tool. Each grip may include one ormore features configured to enhance a surgeon’s ability to grasp andmanipulate the deployment device and associated patch body into positionat the treatment site. As shown, each grip 180 may have an annularconfiguration to enhance the ability for a user to grasp the grip.Additionally or alternatively, other grip configurations and/or featuresmay be employed as should be apparent to one of skill in the art.

Each grip 180 may be movable relative to the support body to facilitatemanipulation of the patch body and the support body into the reducedconfiguration for insertion through a surgical opening into a patient.For example, and without limitation, each grip may be foldable, pivotalor flexible relative to the support body.

Each grip may 180 be centrally located on the support body. As shown, apair of grips 180 may be located along the second axis 60 of the supportbody and on opposite sides of the first axis 58. However, any suitablegrip arrangement may be employed as should be apparent to one of skillin the art. For example, and without limitation, the grips may belocated between the second end 162 and the second axis 60 of the supportbody.

In one embodiment, the support body 52 may include a resilient supportmember to help deploy the support body, and thereby the patch, into anexpanded configuration, such as a planar configuration. As illustratedin FIG. 39 , the resilient support member 181 may include a framestructure with an outer portion 183 configured to extend along the outermargin of the support body and an inner portion 185 configured to extendalong the first axis 58 of the support body. The outer portion 183 maybe configured as a continuous loop or ring that extends along the outermargin of the support body. As shown in FIGS. 37-38 , the support member181 may be positioned at the outer peripheral edge 56 of the supportsegment. However, the support member may be spaced inwardly from theouter peripheral edge and/or at discrete locations throughout the bodyof the support segment as should be apparent to one of skill in the art.As also shown in FIGS. 37-38 , the handle base 170 may be attached tothe inner portion of the support member.

As illustrated, the outer portion 183 of the support member may have anannular configuration and the inner portion 185 may have an elongatedconfiguration that extends from the first end 156 to the second end 162of the support body. Each portion of the support member may have aselected width and thickness to provide a desired degree of resilienceor rigidity. The outer portion of the support member may have agenerally oval configuration that corresponds to the shape of thesupport body. However, the support member may have any suitable shapeand/or cross section as should be apparent to one of skill in the art.

Applying a pulling force F on the handle, as illustrated in FIG. 40 ,encourages the support body 52 to pivot and fold into a reducedconfiguration, such as a non-planar configuration. As illustrated,pulling the handle 54 in an outward direction away from the patch body22 draws the second end 162 of the support body in an outward directionaway from the patch body. Directing the pulling force toward the outerperipheral edge at the second end of the support body causes at least asegment of the second portion 154 to lift and pivot about a regiongenerally parallel to the second axis 60 while also folding about thefirst axis 58 as the support body is withdrawn through the accessopening 36 of the pocket. Such an arrangement may reduce the pullingforce required to remove the deployment device from the pocket of thepatch body with minimal, if any, spraying of bodily fluids resultingfrom the deployment device being withdrawn from the surgical site.

For some applications, rather than lifting the second end of the supportbody in an upward direction as described above, it may be desirable topull the second end of the support body in a downward direction to betucked below the support body as the handle is pulling the support bodyupwardly away from the patch body. Such an arrangement, if desired, mayhelp reduce the amount of drag and pulling force associated withwithdrawing the support body from the patch pocket.

In one embodiment as shown in FIGS. 41-49 , the handle 54 may include ahandle pull 169 that extends through a region of the second portion 154of the support body 52 located inward from the second end 162 of thesupport body. The support body may include a passage 191, such as ahole, slot, or other suitable opening, for permitting a distal portion193 of the handle pull to pass through the support body. The distalportion 193 of the handle pull may be located along the first axis 58adjacent the second side of the support body with the remainder of thehandle pull located along the first axis but adjacent the first side ofthe support body. In this manner, the deployment device employs anover-under arrangement for the handle.

As shown, the handle 54 may be arranged to extend along the first axis58 toward the first end 156 of the support body. The handle pull 169 maybe attached to the support body adjacent the second end 162 using afastener 172, including a rivet or screw, or otherwise secured, such asby welding or bonding with an adhesive, as should be apparent to one ofskill in the art.

In one embodiment as shown in FIGS. 41-44 , the support body may includea resilient support member 195 to help deploy the support body, andthereby the patch, into an expanded configuration, such as a planarconfiguration. As illustrated, the resilient support member 195 mayinclude a frame structure configured to extend along the outer margin ofthe support body. The support member 195 may be configured as acontinuous loop or ring that extends along the outer margin of thesupport body. As shown, the support member may be positioned at theouter peripheral edge 56 of the support segment. However, the supportmember may be spaced inwardly from the outer peripheral edge and/or atdiscrete locations throughout the body of the support segment as shouldbe apparent to one of skill in the art.

As illustrated, the support member 195 may have an annularconfiguration. The support member may have a selected width andthickness to provide a desired degree of resilience or rigidity. Asshown in FIG. 44 , the support member 195 may have a generally ovalconfiguration that corresponds to the shape of the support body.However, the support member may have any suitable shape and/or crosssection as should be apparent to one of skill in the art.

Rather than using a separate support member, it may be desirable toconstruct the support body from a single sheet of material that aloneprovides the desired amount of flexibility, foldability, rollability,resiliency and support. Such an arrangement may reduce costs associatedwith fabricating and/or assembling the support body.

As shown in FIGS. 45-47 , the support body 52 may be formed from a sheetof material that alone provides a desired balance of flexibility,stiffness and resilience for allowing the support body to be collapsedand expanded while providing support for the patch. For example andwithout limitation, the support body may be fabricated from a sheet ofplastic material that provides the support body with the desired supportproperties, as well as other properties including, but not limited to,strength and/or stress crack resistance.

Any of the deployment devices of FIGS. 41-47 may include one or moregrips and/or a handle fastening arrangement that releasably secures aportion of the handle to the support body at a location that providessufficient leverage for manipulating and/or positioning the support bodyand the patch. In one embodiment, the deployment devices may employgrips and/or a handle fastening arrangement as described above inconnection with FIGS. 37-38 .

Applying a pulling force F on the handle pull 54, as illustrated inFIGS. 48-49 , encourages the support body 52 to pivot and fold into areduced configuration, such as a non-planar configuration. As shown inFIG. 49 , pulling the handle in an outward direction away from the patchbody pulls the second end 162 of the support body downwardly toward thepatch body 22 and toward the second axis 60 of the support body causingthe second portion 154 of the support body to fold, bend, roll orotherwise collapse inwardly and become tucked below the second side ofthe support body. The outward pulling force F on the handle also causesat least a segment of the second portion 154 to lift and pivot about aregion generally parallel to the second axis 60 while also folding aboutthe first axis 58 as the support body is withdrawn through the accessopening 36 of the pocket. Such an arrangement may reduce the pullingforce required to remove the deployment device from the pocket of thepatch body with minimal, if any, spraying of bodily fluids resultingfrom the deployment device being withdrawn from the surgical site.

In several embodiments described above, the support body 52 and/or thesupport segments 66, 68 may include a resilient support member to helpdeploy the support body, and thereby the patch, into an expandedconfiguration. The stiffness or rigidity of the support member may bevaried depending on the amount of collapsibility and support desired forthe support body.

In one embodiment, the support member(s) may be formed from a sheet ofmedical grade polyethylene terephthalate glycol (PETG) having athickness of 0.015 inches, such as available from Pacur LLC of OshkoshWI. The material may be laser cut into the desired configuration havingan annular width of 1 cm along the entire length of the support member.However, the thickness and/or width of the support member or portions ofthe support member may be varied to provide a desired degree ofresilience or rigidity. For example, and without limitation, the supportmember may have a width of 0.5 cm to 2 cm. The width may be constantalong the entire support member or different portions of the supportmember may have different widths and/or thicknesses. For example, andwithout limitation, the center portion of the support member may have awidth that differs from the width of the outer portion. However, thesupport member(s) may be fabricated from any suitable material,including shape memory materials such as Nitinol, which provides adesired balance of flexibility, stiffness and resilience for allowingthe support body to be collapsed and expanded while providing supportfor the patch as should be apparent to one of skill in the art.

In one embodiment, the support member may be sandwiched between twolayers of flexible material and may or may not be physically attachedthereto. The layers of flexible material may help protect underlyingtissue and/or adjacent sensitive organs, such as the intestines or otherviscera, from unintentional penetration by the fixation elements duringfixation of the patch about the hernia defect. When inserted into thepocket, a surgical instrument may be moved along a surface of thesupport body into position for delivering a fixation element. Thesupport segments may be constructed of material that is difficult topenetrate with fixation tools and fixation elements. The material of thesupport segments may also have a lubricity that facilitates sliding afixation tool along the surface into position, as well as facilitateinsertion and withdrawal of the support body into and from the patch.

In one embodiment, the support body or support segments may include twolayers of 30 Denier ripstop nylon coated with a 0.003 inch thermoplasticurethane, such as available from Brookwood Companies, Inc. of New York,NY. The support member(s) may be laminated with the layers of nylonmaterial. For example, a support member may be placed between the layersof material with the urethane coating of each layer facing inwardlytowards the support member. The stack of materials may then be placedbetween stainless steel shims that are rolled through a standarddesk-top laminator to join the materials together. However, the supportmember may be coupled to the support segment in any suitable manner asshould be apparent to one of skill in the art. For example, and withoutlimitation, the support member may be tightly or loosely held within achannel formed by a pair of seams joining the layers of materialtogether, such as by stitching. Rather than being sandwiched, thesupport member may overlie or underlie and be attached to a layer ofmaterial with stiches or a bonding agent, or be fused with ultrasonic,induction, vibration, infrared/laser welding and the like. Moreover, thelayers of the support body may be fabricated from any suitable materialthat provides a desired amount of flexibility, puncture resistanceand/or lubricity as should be apparent to one of skill in the art.

In several embodiments described above, the support body 52 and/or thesupport segments 66, 68 may be formed from a sheet of material thatalone provides a desired balance of flexibility, stiffness andresilience for allowing the support body to be collapsed and expandedwhile providing support for the patch. For example, the support body maybe formed from one or more sheets of plastic material including, but notlimited to, polytetrafluoroethylene (PTFE), polypropylene, polyethylene,and polyethylene terephthalate glycol (PETG). It is also contemplatedthat the support body may be formed of an elastomeric materialincluding, but not limited to, silicone. When formed of an elastomericmaterial, the support body may have sufficient flexibility such thatpreformed features may be unnecessary to facilitate folding, bending orflexing.

In one embodiment, the support body and/or each support segment mayinclude a laminated sheet formed from multiple layers ofpolytetrafluoroethylene (PTFE) material. The number, thickness and/ororientation of individual layers relative to each other may be selectedto provide the laminated sheet with desired properties for flexibility,stiffness and/or resilience, as well as multidirectional strength andstress crack resistance. The PTFE material may also provide lubricitythat may facilitate insertion and withdrawal of the support segmentsinto and from the patch pocket, as well as facilitate movement of afixation device along the surface of the support segments. The materialmay be cut to the desired configuration for the support body and/or thesupport segments.

In one embodiment, the support body and/or the support segments may befabricated from a sheet of CROSSFILM material, which is a laminatedsheet of PTFE, available from Textile Coated International ofManchester, NH. The material may have a thickness of 0.012 inches to0.020 inches. However, the support body and/or the support segments maybe fabricated from any suitable material that provides a desired balanceof flexibility, stiffness and resilience for allowing the support bodyto be collapsed and expanded while providing support for the patch asshould be apparent to one of skill in the art.

The handle may be formed of a plastic material including, but notlimited to, polypropylene, polyethylene and polytetrafluoroethylene(PTFE), that provides the desired level of stiffness, flexibility,foldability and rollability suitable for a particular application. Inone embodiment, the handle may be formed from a polypropylene materialhaving a thickness of 0.030 inches, such as FORMEX GK-30BK availablefrom ESPE Manufacturing Co. of Schiller Park, IL. The handle may belaser cut to the desired configuration from a sheet of the material.However, the handle may be formed from any suitable material using anysuitable fabrication process as should be apparent to one of skill inthe art.

Various techniques may be employed to reduce the assembled patch anddeployment device to a smaller configuration suitable for deliverythrough an opening, such as a surgical incision. For example, andwithout limitation, the assembled patch and deployment device may berolled up into a cylinder. In one embodiment, the assembled patch anddeployment device may be rolled by hand about an axis generally parallelto the first axis with the handle pull positioned along the first axisand the handle base positioned along the second axis. For example, oneedge of the patch body intersected by the second axis may be rolled in adirection along the second axis toward the opposite edge of the patchbody intersected by the second axis.

The patch body 22 may have any form appropriate for repairing a herniadefect. The patch may be substantially flat or may be arranged with aconcave, convex, or a combination concave/convex surface. The distancebetween edges of the patch body along the first axis 28 may be greaterthan the distance between edges of the patch body along the second axis30; that is, the patch body may be elongated along the first axis. Theshape of the patch body when viewed along the first axis may bedifferent than the shape of the patch body when viewed along the secondaxis. For example, and without limitation, the edges of the patch bodyintersected by the first axis may be generally round while the edges ofthe patch body intersected by the second axis may be linear and runparallel to the first axis. Other patch body configurations arecontemplated as should be apparent to one of skill in the art.

The patch body 22 may be formed of a porous material, such as a knitfabric, woven or non-woven fabric, or may be composed of a solid,substantially non-porous, or micro-porous material. The patch body maybe formed of one or more layers of the same or dissimilar material, andthe layers may be stacked one on top of the other, side-to-side, orinclude a combination of both stacking arrangements. The patch body maybe formed with portions that are tissue infiltratable and other portionsthat are less tissue infiltratable or are non-tissue infiltratable,providing selected areas of the repair device with different tissueingrowth and adhesion resistant properties. The patch body may be formedof permanent material, resorbable material, or a combination ofpermanent and resorbable materials. It should be appreciated that thepatch body may be formed of any biologically compatible material,synthetic or natural, suitable for repairing a tissue or muscle walldefect as would be apparent to one of skill in the art.

A representative embodiment of the hernia repair patch and arepresentative procedure for using same is now described. A herniarepair patch configured to repair a ventral hernia includes a patch bodyhaving a tissue infiltratable layer on one side and a barrier layer onthe other side. The tissue infiltratable layer may include one or moresheets of surgical mesh fabric, such as a polypropylene knit. Thebarrier layer may be a sheet of synthetic or natural barrier material;for example, and without limitation, a sheet of ePTFE may be stitched,heat fused or otherwise connected to a polypropylene sheet. Anotheroption is to embed the polypropylene knit into a film of SEPRA(bioresorbable hydrogel barrier). The polypropylene side would face theabdominal wall and the ePTFE or SEPRA side would face the viscera.

A flat, generally oval-shaped, support body includes first and secondsupport segments coupled to a handle base at hinge points located alongthe second axis of the support body. A handle pull is pivotally coupledto the handle base and is located at the approximate center of thesupport body. The support body is configured to collapse for insertioninto and withdrawal from a pocket in the patch body. The support bodyhas a generally oval shape that corresponds to the shape and occupies asubstantial portion of the pocket.

The center of the support body is registered with the center of thepatch body, with the outer peripheral edge of the support body generallyfollowing the periphery of the pocket of the patch body. The supportbody is collapsed from a planar, expanded configuration larger than theaccess opening to a non-planar configuration smaller than the accessopening for insertion into the pocket of the patch body. Thereafter, thesupport body is opened to the expanded configuration within the pocket,securing the patch body to the deployment device. The handle pullextends through the access opening and out beyond the tissueinfiltratable side where it will be accessible for manipulation to hoistthe support body and associated patch body against the abdominal wall.

The flexible patch and deployment device are rolled into a reducedconfiguration and then delivered through an opening, such as anincision, into a patient. Upon exiting the incision, the support bodyreturns to a larger shape, spreading the patch body into an expandedconfiguration. The handle pull extending from the patch may be pulledthrough the incision in the abdominal wall and then manipulated outsideof the patient to hoist the support body and assembled patch bodyagainst the abdominal wall about the defect. With the patch positionedagainst the abdominal wall, fixation elements, such as a suture, tack,or staple, are delivered through the pocket and applied through theperiphery of the patch adjacent the pocket and, or if desired, throughthe central opening in the support body.

With the patch securely fixated to the abdominal wall, the deploymentdevice may then be removed from the anchored patch. For example, thesurgical team may use the handle pull to grip and pull the support bodyout of the pocket and away from the patch. In response to the pullingforce, the support body and the handle base, if so configured, collapseby pivoting and folding of the support segments and transform to acollapsed configuration (e.g., generally flattened trapezoidal) allowingthe support body to slide through the access opening of the patch body.Once separated from the patch, the support body may be withdrawn throughthe same opening, such as a surgical incision, via which the assembleddeployment device and patch were originally delivered to the surgicalsite. The collapsed deployment device may be removed from the treatmentsite with minimal, if any, splashing of bodily fluids.

For purposes of this patent application and any patent issuing thereon,the indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.” The phrase“and/or,” as used herein in the specification and in the claims, shouldbe understood to mean “either or both” of the elements so conjoined,i.e., elements that are conjunctively present in some cases anddisjunctively present in other cases. Multiple elements listed with“and/or” should be construed in the same fashion, i.e., “one or more” ofthe elements so conjoined. Other elements may optionally be presentother than the elements specifically identified by the “and/or” clause,whether related or unrelated to those elements specifically identified.

The use of “including,” “comprising,” “having,” “containing,”“involving,” and/or variations thereof herein, is meant to encompass theitems listed thereafter and equivalents thereof as well as additionalitems.

It should also be understood that, unless clearly indicated to thecontrary, in any methods claimed herein that include more than one stepor act, the order of the steps or acts of the method is not necessarilylimited to the order in which the steps or acts of the method arerecited.

The foregoing description of various embodiments are intended merely tobe illustrative thereof and that other embodiments, modifications, andequivalents are within the scope of the invention recited in the claimsappended hereto.

What is claimed is:
 1. A deployment device for a soft tissue repairprosthesis, the deployment device comprising: a self-expanding supportbody to be releasably coupled to the soft tissue repair prosthesis toassist in spreading the soft tissue repair prosthesis from a reducedconfiguration to an expanded configuration, the support body beingcollapsible from an expanded configuration to a reduced configuration;and a handle including a distal end coupled to the support body and afree end opposite the distal end, the handle including an intermediateportion between the distal end and the free end that is releasablysecurable to the support body to position the soft tissue repairprosthesis relative to a soft tissue defect when the support body iscoupled to the soft tissue repair prosthesis, the support body beingreleasable from the soft tissue repair prosthesis with a pulling forceon the free end of the handle in an outward direction away from the softtissue repair prosthesis when the intermediate portion of the handle isreleased from the support body and the soft tissue repair prosthesis isin the expanded configuration, wherein the support body is manipulableinto the reduced configuration with the soft tissue repair prosthesisfor insertion through a surgical opening into a patient.
 2. Thedeployment device according to claim 1, wherein the expandedconfiguration of the support body has a planar configuration and thereduced configuration of the support body has a non-planarconfiguration.
 3. The deployment device according to claim 1, whereinthe support body includes a handle fastener to releasably secure theintermediate portion of the handle.
 4. The deployment device accordingto claim 3, wherein the intermediate portion of the handle includes akeyhole opening configured to releasably engage the handle fastener. 5.The deployment device according to claim 1, wherein the support body hasa first axis and a second axis perpendicular to the first axis, thefirst axis and the second axis intersecting at approximately a center ofthe support body, the support body including first and second portionson opposite sides of the second axis, the distal end of the handle beingcoupled to the second portion of the support body along the first axis.6. The deployment device according to claim 5, wherein the support bodyincludes an outer periphery, the distal end of the handle being coupledproximate to the outer periphery of the support body.
 7. The deploymentdevice according to claim 5, wherein the handle fastener is locatedalong the first axis.
 8. The deployment device according to claim 7,wherein the handle fastener is located on the second portion of thesupport body.
 9. The deployment device according to claim 1, wherein thesoft tissue repair prosthesis comprises a patch body including a pocketand an access opening configured to provide access to the pocket,wherein the support body is configured to be removably inserted into thepocket through the access opening to assist in spreading the patch bodyfrom the reduced configuration to the expanded configuration, thesupport body being insertable into and removable from the pocket whencollapsed from the expanded configuration to the reduced configuration,and wherein the free end of the handle is extendable away from thesupport body and through the access opening when the support body isremovably inserted in the pocket of the patch body, the support bodybeing removable from the pocket with a pulling force on the free end ofthe handle in an outward direction away from the patch body when thepatch body is in the expanded configuration.
 10. The deployment deviceaccording to claim 9, in combination with the soft tissue repairprosthesis.
 11. The deployment device in combination with the softtissue repair prosthesis according to claim 10, wherein the patch bodyincludes first and second layers attached together to form the pockettherebetween, one of the first and second layers including the accessopening therethrough to provide access to the pocket.
 12. The deploymentdevice in combination with the soft tissue repair prosthesis accordingto claim 10, wherein the pocket has an outer periphery, the outerperipheral edge of the support body configured to follow the outerperiphery of the pocket.
 13. The deployment device in combination withthe soft tissue repair prosthesis according to claim 10, wherein thesupport body is configured to substantially occupy the pocket.